Renal Cell Carcinoma

Immunotherapy Changes First-Line Paradigm in Advanced RCC

Zosia Chustecka
September 11, 2017

New data are set to change the paradigm for the first-line treatment of advanced renal cell carcinoma (RCC), after a phase 3 trial showed significantly improved overall survival (OS) with immunotherapy in comparison to standard care with sunitinib (Sutent, Pfizer).
The data come from the CheckMate-214 study, which was stopped early by the data monitoring committee after it showed that patients with advanced RCC were living significantly longer when treated first line with the combination of nivolumab (Opdivo, Bristol-Myers Squibb) and ipilimumab (Yervoy, Bristol-Myers Squibb).
Until now, nothing has beaten sunitinib in a randomized phase 3 clinical trial, and it was "brave to choose it as a comparator," said Manuela Schmidinger, MD, from the Medical University of Vienna, Austria. She pointed out that this is the first phase 3 study to show a statistically significant OS benefit.
This new study changes the paradigm, and it establishes a new standard of care for the first-line treatment of advanced RCC, she commented. Dr Schmindinger was not involved in the study and acted as discussant after it was presented here in a presidential session at the European Society of Medical Oncology (ESMO) 2017 Congress.
Several others agreed with her. This is practice changing, commented Markus Joerger, MD, PhD, assistant professor of medical oncology and clinical pharmacology, St. Gallen Cancer Center, Switzerland, who chaired the ESMO press briefing at which the study was highlighted.
Reacting to the new findings, Maria de Santi, MD, the University of Warwick, United Kingdom, was enthusiastic. "This means that immunotherapy is not only a new option for these patients, it should become the standard of care," she told Medscape Medical News. The study was highly significant on two of three endpoints, she noted: response rate and OS. It did not reach the predetermined statistical significance for progression-free survival (PFS), but this is often seen with immunotherapy, she said.

Dr Maria de Santi
Dr De Santi also commented that immunotherapy should be considered to have trumped pazopanib (Votrient, GlaxoSmithKline), which is another standard of care in the first-line setting in advanced RCC. Although the current trial compared immunotherapy against sunitinib, she noted that pazopanib has shown similar efficacy, and she does not feel that a trial comparing immunotherapy with pazopanib used as the control was necessary.